1
Filed with the Securities and Exchange Commission on December 15, 1998
Registration No. 333-68585
================================================================================
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
--------------------
FORM S-3/A-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
--------------------
ATRIX LABORATORIES, INC.
------------------------------------------------------
(Exact name of registrant as specified in its charter)
Delaware 84-0402207
- --------------------------------------------- -------------------
(State or other jurisdiction of incorporation (I.R.S. Employer
or organization) Identification No.)
2579 Midpoint Drive, Fort Collins, Colorado 80525. (970) 482-5868
-----------------------------------------------------------------
(Address, including ZIP code, and telephone number,
including area code, of registrant's principal executive offices)
--------------------
Brian G. Richmond
2579 Midpoint Drive, Fort Collins, Colorado 80525. (970) 482-5868
-----------------------------------------------------------------
(Name, address, including ZIP code, and telephone number,
including area code, of agent for service)
--------------------
COPIES TO:
Warren L. Troupe, Esq.
Morrison & Foerster LLP
370 17th Street, Suite 5200, Denver, Colorado 80202
(303) 592-1500
Approximate date of commencement of proposed sale to the public: From time to
time after the effective date of the Registration Statement.
If the only securities being registered on this Form are being offered pursuant
to dividend or interest reinvestment plans, please check the following box. |_|
If any of the securities being registered on this Form are to be offered on a
delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, other than securities offered only in connection with dividend or interest
reinvestment plans, please check the following box. |_|
If this Form is filed to register additional securities for an offering pursuant
to Rule 462(b) under the Securities Act, please check the following box and list
the Securities Act registration statement number of the earlier effective
registration statement for the same offering. |_|
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under
the Securities Act, please check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. |_|
If delivery of this prospectus is expected to be made pursuant to Rule 434,
please check the following box. |_|
CALCULATION OF REGISTRATION FEE
===========================================================================================================
Title of each class of Amount to be Maximum Offering Price Amount of
securities to be registered registered Per Unit(1) registration fee(1)
- ---------------------------------- --------------- ----------------------------- ----------------------
Common Stock 37,860
Common Stock underlying
conversion of Warrant 6,750
Common Stock issuable upon
Earn-Out Events(2) 227,152
-------
TOTAL: 271,762 $12.00 $906.60
===========================================================================================================
(1)Estimated solely based solely for the purpose of computing the amount of the
registration fee pursuant to Rule 457(c) under the Securities Act of 1933, as
amended.
(2)For purposes of estimating the number of shares of Common Stock to be
included in this Registration Statement the Registrant used a price per share
of $10.30 to determine the maximum number of shares issuable upon the
attainment of the Earn-Out Events set forth in the Agreement and Plan of
Reorganization.
(3)Pursuant to Rule 416, this Registration Statement also registers an
indeterminate number of shares of Common Stock as may be issued or become
issuable upon the exercise of the Warrant in accordance with its terms to
prevent dilution resulting from stock splits, stock dividends or similar
transactions.
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES
AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE
A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT
SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF THE
SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(a),
MAY DETERMINE.
2
SUBJECT TO COMPLETION DATED DECEMBER 15, 1998
PROSPECTUS
271,762
ATRIX LABORATORIES, INC.
COMMON STOCK
$.001 PAR VALUE
This Prospectus relates to the offer and sale of an aggregate of
271,862 shares of the Common Stock of Atrix Laboratories, Inc. which were issued
to certain persons in connection with the acquisition by Atrix of ViroTex
Corporation. This amount also includes 227,152 shares which may be issued to
such persons in the future if ViroTex Corporation meets certain performance
criteria and 6,750 shares issuable upon the exercise of a Warrant issued to
GulfStar Investments, Limited.
The shares may be offered and sold by the selling stockholders from
time to time in open market or privately negotiated transactions which may
involve underwriters or brokers. Atrix will not receive any proceeds from the
sale of the shares covered by this Prospectus.
FOR INFORMATION CONCERNING CERTAIN RISKS RELATED TO AN INVESTMENT IN
THE SHARES SEE "RISK FACTORS" BEGINNING ON PAGE 3.
NETHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES
COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SHARES OR DETERMINED IF THIS
PROSPECTUS IS TRUTHFUL OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
THE INFORMATION IN THIS PROSPECTUS IS NOT COMPLETE AND MAY BE CHANGED.
WE MAY NOT SELL THESE SHARES UNTIL THE REGISTRATION STATEMENT FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION IS EFFECTIVE. THIS PROSPECTUS IS NOT AN OFFER
TO SELL THESE SHARES AND IT IS NOT SOLICITING AN OFFER TO BUY THESE SHARES IN
ANY STATE WHERE THE OFFER OR SALE IS NOT PERMITTED.
The date of this Prospectus is December __, 1998.
1
3
AVAILABLE INFORMATION
Atrix files annual, quarterly and special reports, proxy statements and
other information with the Securities and Exchange Commission ("SEC"). You may
read and copy any documents we file at the SEC's public reference facilities at
450 Fifth Street, N.W., Room 1024, Washington, D.C. 20549. You may obtain
information on the operation of the Public Reference Room by calling the SEC at
1-800-SEC-0330. Our SEC flings are also available on the SEC's World Wide Web
site at www.sec.gov. Additional information about Atrix can be found at our
World Wide Web site at www.atrixlabs.com.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The SEC allows us to "incorporate by reference" information from other
documents that we file with them, which means that we can disclose important
information by referring to those documents. The information incorporated by
reference is considered to be part of this Prospectus, and information that we
file later with the SEC will automatically update and supersede this
information. We incorporate by reference the documents listed below and any
future filings we make with the SEC under Sections 13(a), 13(c), 14 or 15(d) of
the Securities Exchange Act of 1934 prior to the sale of all the shares covered
by this Prospectus: (i) Atrix's Annual Report on Form 10-K for the fiscal year
ended December 31, 1997, (ii) Atrix's Quarterly Reports on Form 10-Q for the
quarters ended March 31, 1998, June 30, 1998 and September 30, 1998; (iii)
Atrix's Current Report on Form 8-K dated November 24, 1998; and (iv) Atrix's
Registration Statement on Form 8-A filed on January 12, 1990, registering the
Common Stock under Section 12(g) of the Exchange Act.
We will provide a copy of any or all of such documents (exclusive of
exhibits unless such exhibits are specifically incorporated by reference herein)
without charge, to each person to whom this Prospectus is delivered, upon
written or oral request to Brian G. Richmond, Vice President, Finance 2579
Midpoint Drive, Fort Collins, Colorado 80525, telephone (970) 482-5868.
You should rely only on the information incorporated by reference or
provided in this Prospectus or any supplement. We have not authorized anyone
else to provide you with different information. The selling stockholders will
not make an offer of these shares in any state where the offer is not permitted.
You should not assume that the information in this Prospectus or any supplement
is accurate as of any date other than the date on the front of these documents.
ADDITIONAL INFORMATION
This Prospectus is part of a registration statement that we filed with
the SEC. The registration statement contains more information than this
Prospectus regarding Atrix and its Common Stock, including certain exhibits. You
can get a copy of the registration statement from the SEC at the address listed
above or from its Internet site.
FORWARD LOOKING INFORMATION
This Prospectus, and the documents incorporated by reference, may
contain "forward-looking" statements as described in Section 27A of the
Securities Act and Section 21E of the Securities Exchange Act of 1934, as
amended. These forward looking statements usually include words like "believes,"
"anticipates" and "expects" and describe our expectations for the future. Of
course, these expectations may not be met in important ways for a variety of
reasons including those listed in this Prospectus under the heading "Risk
Factors." We are not required to update any forward-looking statements we make
and we may not.
2
4
RISK FACTORS
In addition to the other information contained in this Prospectus, the
following risk factors should be carefully considered in evaluating Atrix and
its business before purchasing any of the shares offered hereby.
Atrix cautions the reader that this list of risk factors may not be exhaustive.
EARLY STAGE OF DEVELOPMENT
We have commenced commercial sales of only three products, the ATRISORB
GTR Barrier, the first commercial shipment of which occurred in March 1996, our
veterinary product which has been marketed by a third party since November 1997
and the ATRIDOX(TM) product, which recorded its first sales in September 1998.
Atrix has not recognized significant revenue from product sales to date. We do
not have regulatory approval or clearance to market any other product. All of
our other potential products are at an early stage of development and will
require extensive research, development, and preclinical and clinical testing
prior to commercialization. In addition, all of our potential products will be
subject to an extensive, time consuming and costly regulatory approval or
clearance process prior to commercialization. There can be no assurance that any
such potential products will prove safe and effective in clinical trials, obtain
required regulatory approvals or clearance, or be capable of commercial scale
production at an acceptable cost, or that any clinical trials will be completed
on schedule, at or below budget or at all. Any failure of our to achieve
technical feasibility, demonstrate safety, achieve clinical efficacy, obtain
regulatory approvals or clearances or successfully manufacture or commercialize
our products would have a material adverse effect on Atrix.
HISTORY OF OPERATING LOSSES; UNCERTAINTY OF FUTURE PROFITABILITY
We have sustained losses in each year of operation, and have incurred
an accumulated deficit of approximately $43.0 million through September 30,
1998. Prior to March 1996, Atrix had not received any revenues from product
sales. We expect to continue to incur losses due to expenses for research,
development, manufacturing, sales, marketing, and interest payable on our
$50,000,000 of 7% Convertible Subordinated Debt due 2004, which expenses are
expected to be in excess of anticipated revenues. In particular, we expect to
incur substantial manufacturing, sales and marketing expenses in connection with
the commercial launch of the Atridox(TM) product. There can be no assurance that
we will ever achieve substantial revenues from product sales or profitability,
or that profitability will be sustained for any particular period of time.
DEPENDENCE ON RELATIONSHIP WITH BLOCK
Our ability to successfully commercialize our products will depend to a
significant extent on the marketing and sales efforts of Block Drug Corporation
over which we have limited control. We have an agreement with Block Drug
pursuant to which they have the exclusive rights to market the ATRIDOX(TM)
product, the ATRISORB(TM) and the ATRISORB-DOXY(TM) product in North America. We
anticipate that royalties and manufacturing margins from Block Drug will
constitute a substantial portion of our revenues. However, there can be no
assurance that Block Drug will be able to establish effective marketing, sales
and distribution capabilities for these products or will be successful in
gaining market acceptance for these products. Moreover, Block Drug has the right
to terminate its agreement with us at any time with or without cause on
12-months notice. The election by Block Drug to discontinue its participation in
the commercialization, marketing and distribution of the ATRIDOX product, the
ATRISORB GTR Barrier or the ATRISORB-DOXY product could have a material adverse
affect on Atrix.
LEVERAGE
At September 30, 1998, Atrix's total long-term debt and stockholders'
equity were $50.0 million and $30.2 million, respectively. The Indenture which
governs our Subordinated Notes does not restrict our ability to incur additional
indebtedness. Atrix's ability to satisfy its obligations will be dependent upon
its future performance, which is subject to prevailing economic conditions and
financial, business and other factors, including factors beyond our control.
There is no assurance that Atrix's operating cash flow will be sufficient to
meet its debt service requirements or to repay the Subordinated Notes at
maturity or earlier upon the occurrence of a "repurchase event" which could
occur in the event of a change in control of Atrix or a termination of trading.
3
5
SIGNIFICANT GOVERNMENT REGULATION; UNCERTAINTY OF OBTAINING REGULATORY APPROVALS
Atrix's research, preclinical development, clinical trials,
manufacturing, marketing and the distribution of its products in the United
States and other countries are subject to extensive regulation by numerous
governmental authorities including, but not limited to, the United States Food
and Drug Administration ("FDA"). Prior to marketing in the United States, any
drug we develop must undergo rigorous preclinical (animal) and clinical (human)
testing and an extensive regulatory process implemented by the FDA. Satisfaction
of such regulatory requirements, which includes satisfying the FDA that the
product is both safe and effective for its proposed indications, typically takes
several years or more, depending upon the type, complexity, and novelty of the
product, and requires the expenditure of substantial resources. Failure to
comply with FDA or other applicable regulatory requirements may subject a
company to administrative sanctions or judicially imposed sanctions such as
civil penalties, criminal prosecution, injunctions, product seizure or
detention, product recalls, or total or partial suspension of production. In
addition, noncompliance may result in the FDA's refusal to approve pending new
drug applications or supplements to approved applications.
We received FDA approval for the ATRIDOX product in September 1998 and
the ATRISORB GTR Barrier product in 1996. Promotional activities for these
products, their manufacture and their manufacturing facilities are subject to
continual review and periodic inspections by the FDA. In addition,
identification of certain side effects after a drug is on the market or the
occurrence of marketing problems could cause subsequent withdrawal of approval,
reformulation of the drug, additional preclinical or clinical testing and
changes in labeling.
Atrix is also subject to foreign regulatory requirements in connection
with the research, development, manufacture and sale of its products abroad.
These requirements vary widely from country to country, and there can be no
assurance that we will be able to achieve or remain in compliance with any such
requirements. Any failure to achieve or remain in compliance with foreign
requirements, notwithstanding authorizations to legally market the products in
the United States, could have a material adverse effect on Atrix.
RELIANCE ON PATENTS AND PROPRIETARY RIGHTS
Atrix considers patents and proprietary rights to be materially
significant to its business. As of September 30, 1998, we maintained 27 United
States and 15 foreign patents, and have 14 United States and 41 foreign patent
applications pending. We believe that our ATRIGEL system, upon which the
ATRISORB GTR Barrier, the ATRIDOX product and all of our products under
development are based, is protected by claims contained in these patents and in
pending patent applications. We intend to aggressively defend our patent
position and to file additional patent applications in the future. However,
there can be no assurance that any of our present or future patents will provide
Atrix with significant protection or will not be challenged. The patent
positions of drug delivery companies, including Atrix's, are uncertain and
involve complex legal and factual issues. Accordingly, we anticipate that any
attempt to enforce our patents would be time consuming and costly. Furthermore,
there can be no assurance that any such attempted enforcement would be
successful, or that third parties will not succeed in circumventing or
invalidating any one or more of Atrix's patents. Moreover, the laws of some
foreign countries do not protect our proprietary rights to the same extent as do
the laws of the United States. Any invalidation or circumvention of our patents
could have a material adverse effect on Atrix.
There can be no assurance that any of our pending patent applications
will result in the issuance of patents, that the claims filed in any pending
patent application will not be significantly reduced prior to issuance or that
any issued patents will provide significant proprietary protection. Because
patent applications in the United States are maintained in secrecy until patents
issue and publication of discoveries in the scientific or patent literature
often lags behind actual discoveries, we cannot be certain that it was the first
inventor of inventions covered by its pending patent applications or that it was
the first to file patent applications for such inventions. Moreover, we may have
to participate in interference proceedings declared by the Patent and Trademark
Office to determine priority of invention that could result in substantial cost
to Atrix , even if the eventual outcome is favorable to us.
4
6
We are not aware of any patents that we believe would be infringed by
our proposed products. However, there can be no assurance that we have
identified all patents that may pose a risk of infringement by our proposed
products. There can be no assurance that third parties will not assert
infringement claims against Atrix or that any such assertions will not result in
costly litigation or require us to obtain a license to the intellectual property
rights of such parties. There can be no assurance that any such licenses would
be available on terms acceptable to us, if at all. Furthermore, parties making
such claims may be able to obtain injunctive or other relief that could
effectively block our ability to further develop or commercialize our products
in the United States and abroad and could result in the award of substantial
damages. Defense of any lawsuit or failure to obtain any such license could have
a material adverse effect on our business. Finally, litigation, regardless of
outcome, could result in substantial cost to us, both financially and in terms
of diversion of management's attention.
LACK OF COMMERCIAL SCALE MANUFACTURING EXPERIENCE; REGULATORY COMPLIANCE
We have limited experience in manufacturing our products on a
commercial scale. We have manufactured the ATRISORB GTR Barrier at our pilot
manufacturing facility since March 1996. In July 1996, we purchased a 26,000
square foot commercial production facility and completed a number of renovations
to the facility in 1997. The Company has completed validation of the facility
and currently is in the process of validating the production process for the
ATRISORB GTR Barrier, the ATRIDOX product, the ATRISORB-DOXY product and
clinical study supplies for additional products in development. In the third
quarter of 1997 and the third quarter of 1998, we commenced manufacturing the
ATRISORB GTR Barrier and the Atridox product, respectively on a commercial
scale. There can be no assurances that we will be able to manufacture the
ATRISORB GTR Barrier or any other products at an acceptable cost and in
compliance with applicable regulations. Failure or significant delay by Atrix in
complying with applicable regulations would have a material adverse effect on
our business.
Such regulations require, among other things, that each manufacturer
establish a quality assurance program by which it monitors the manufacturing
process and maintains records evidencing compliance with FDA regulations and the
manufacturer's specifications and procedures. Failure to comply with these
requirements can result in, among other consequences, warning letters, civil
penalties, suspensions or losses of regulatory approvals or clearances, product
recalls or seizures, injunctions, orders to cease operations and criminal
penalties. Any failure by us to manufacture its present and future products in
compliance with applicable regulations could have a material adverse effect on
Atrix.
LACK OF SALES AND MARKETING EXPERIENCE
We have limited experience in the sale and marketing of our products.
In December 1996, we entered into an agreement with Block Drug for the
commercialization of certain of our products. Under the current terms of the
agreement with Block Drug, Block Drug has the rights to market the ATRISORB-GTR
Barrier, the ATRIDOX product and the ATRISORB-DOXY product in North America. We
intend to internally develop marketing channels for the ATRISORB GTR Barrier,
the ATRISORB-DOXY product and the ATRIDOX product in Europe.
We have engaged distributors to market the ATRISORB GTR Barrier in
Europe, and expect to utilize independent distributors, corporate partners or
implement our own direct sales force for foreign sales of its future products.
We anticipate that all such distributors will handle products of multiple
vendors, potentially including products that compete directly with our products
offered by such distributors. We will have limited or no control over the
resources that any independent distributor may devote to the marketing of our
products or to the level of customer service any such distributor provides.
There can be no assurance that we will be able to establish or maintain a
successful direct sales organization in Europe or enter into marketing
agreements with other corporate partners. In addition, there can be no assurance
that there will be sufficient sales of our current or future products to fund
related sales and marketing expenses, many of which must be incurred before
sales commence. Failure to develop a successful sales force, a distribution
network or marketing agreements with corporate partners may have a material
adverse effect on Atrix.
5
7
DEPENDENCE ON THIRD PARTIES
We have entered into several collaborative arrangements, and hope to
enter into additional collaborative arrangements with other companies and
individual dental practitioners covering the research, development, clinical
trials, regulatory approval, manufacture and marketing of various of our
potential products. We believe that our ability to successfully develop our
ATRIGEL system for a wide array of human and animal health care applications
will depend in substantial part on our ability to enter into such collaborative
arrangements. There can be no assurance that we will be able to enter into or
maintain existing or future collaborations, or that any such collaborations will
be successful. Any such failure could have a material adverse effect on our
business. Furthermore, some of our existing collaborations are non-exclusive,
and there can be no assurance that any of our present or future collaborative
partners will not pursue parallel development of other health care products that
may compete directly with our products. Atrix will have limited or no control
over the resources that any partner may devote to our products. There can be no
assurance that any of our present or future collaborative partners will perform
their obligations as expected or will devote sufficient resources to the
research, development, clinical testing, regulatory approval, manufacture or
marketing of our products. We also rely on third parties to manufacture various
components of the ATRISORB GTR Barrier and expect to rely in varying degrees on
contract manufacturers for the ATRIDOX product and other products under
development. There can be no assurance that we will be able to obtain product in
required quantities, of acceptable quality or at a competitive cost from any
such third party manufacturers. Any failure by any of the foregoing third
parties to devote sufficient efforts to the research, development, clinical
testing, regulatory approval, manufacture or marketing of our products could
have a material adverse effect on our business.
ACCESS TO PHARMACEUTICAL COMPOUNDS
Our ability to successfully commercialize its ATRIGEL(R) system will
depend in substantial part on our ability to obtain access to the pharmaceutical
compounds to be delivered thereby. We intend to rely in certain circumstances on
the ability of our collaborative partners to provide access to such
pharmaceutical compounds. There can be no assurance that we will be able to
obtain such access, either directly or through our collaborative partners. The
failure of Atrix to obtain rights to a particular pharmaceutical would preclude
Atrix from developing its ATRIGEL(R) system for delivery of such pharmaceutical.
Furthermore, there can be no assurance that our use of such pharmaceutical will
not be alleged or determined to be infringing on third parties' rights. Any such
failure or infringement could have a material adverse effect on Atrix.
COMPETITION; RAPID TECHNOLOGICAL CHANGE
The drug delivery industry is highly competitive and rapidly evolving,
with significant developments expected to continue at a rapid pace. Our future
success will depend on developing efficient and effective drug delivery products
and technologies. All of our products will compete both with other systems for
delivery of a particular drug and with other forms of treatment of the
indication targeted by such products. The ATRISORB GTR Barrier competes directly
with at least two barrier products, both of which are currently marketed in the
United States. In addition, the ATRIDOX product competes directly with at least
one presently marketed product. We are aware of many competitors in the field of
drug delivery, including competitors developing injectable or implantable drug
delivery systems, oral drug delivery systems, passive transdermal systems,
electrotransport systems, oral transmucosal systems and inhalation systems.
There can be no assurance that any such products or technologies will not render
our product and products under development or technologies uncompetitive or
obsolete. In addition to competing for customers, we also compete with these
companies in seeking and obtaining quality collaborative partners. Most of our
existing or potential competitors, including each party presently selling
products that compete directly with the ATRISORB GTR Barrier and the ATRIDOX
product, have substantially greater research and development capabilities,
experience, manufacturing, marketing, financial and managerial resources than
Atrix. Furthermore, acquisitions of competing drug delivery companies by large
pharmaceutical companies could enhance competitors' financial, marketing and
other resources. Accordingly, our competitors may succeed in developing
competing technologies, obtaining FDA approval or gaining market share for
products more rapidly than Atrix.
YEAR 2000 COMPLIANCE
Currently, many computer systems and software products are coded to
accept only two digit entries in the date code field. These date code fields
will need to accept four digit entries to distinguish 21st century dates from
20th century dates. As a result, many companies' software and computer systems
may need to be upgraded or replaced in order to comply with such "Year 2000"
requirements. Atrix and third parties with which Atrix does business rely on
numerous computer programs in their day to day operations. We are evaluating the
Year 2000 issue as it relates to our internal computer systems and third party
computer systems with which we interact. We expect to incur internal staff costs
as well as consulting and other expenses related to these issues; these costs
will be expensed as incurred. In addition, the appropriate course of action may
include replacement or an upgrade of certain systems or equipment at a
substantial cost. There can be no assurance that the Year 2000 issues will be
resolved in 1998 or 1999. Atrix may incur significant costs in resolving its
Year 2000 issues, however, we believe this issue will not have a significant
adverse impact on our operations.
6
8
DEPENDENCE ON KEY PERSONNEL
Our success is dependent on our ability to retain highly qualified
management and scientific personnel. Competition for such personnel is intense
and the inability to attract additional key employees or the loss of one or more
current key employees could have a material adverse effect on Atrix. There can
be no assurance that we will be successful in retaining requisite personnel in
the future.
UNCERTAINTY OF ADDITIONAL FUNDING
We expect that our existing cash resources, should be sufficient to
fund our operations through 1999. Thereafter, we may need to seek additional
funding; however, there can be no assurance that additional financing will be
available on acceptable terms or at all. If additional funds are raised by
issuing equity securities, further dilution to then existing stockholders may
result. If adequate funds are not available, we may be required to delay, scale
back or eliminate one or more of its research and development programs or obtain
funds through arrangements with collaborative partners or others that may
require us to relinquish certain rights to certain of its technologies, product
candidates or products that we would not otherwise relinquish.
VOLATILITY OF STOCK PRICE
The market prices for securities of drug delivery companies (including
Atrix's) have historically been highly volatile, and the market has from time to
time experienced significant price and volume fluctuations that are unrelated to
the operating performance of particular companies. Future announcements
concerning us or our competitors, including the results of clinical trials,
regulatory approvals, technological innovations or new products, developments in
patent or other proprietary rights and litigation, as well as general market
conditions, may have a significant effect on the market price of the Common
Stock.
CERTAIN ANTI-TAKEOVER PROVISIONS; STOCKHOLDER RIGHTS PLAN
Certain provisions of Atrix's Amended and Restated Certificate of
Incorporation, Amended and Restated Bylaws and Delaware law may delay or
discourage a change of control of Atrix, and, accordingly, adversely effect the
price of the Common Stock. These provisions include establishing a classified
board of directors, permitting cumulative voting in certain circumstances,
allowing the Board of Directors to issue and determine the rights, powers and
preferences of Preferred Stock (as defined herein) without any vote or further
action by the stockholders, establishing a process to enlarge and fill vacancies
on the Board of Directors and deterring certain self-dealing transactions. We
have also adopted a Stockholder rights plan, which may deter or delay attempts
to acquire Atrix. These provisions may discourage certain types of
non-negotiated transactions which would result in a change of control of Atrix
and are expected to encourage persons seeking to acquire control of Atrix to
consult first with the Board of Directors to negotiate the terms of any proposed
business combination or offer. Under applicable Delaware law, the Board of
Directors has the ability to adopt additional anti-takeover measures either in
response to a specific threat or in furtherance of their general fiduciary
duties. The Board of Directors may, from time to time, consider the adoption of
such measures and may adopt additional anti-takeover provisions in the future.
THE COMPANY
Atrix is engaged in the research, development and commercialization of
a broad range of dental, medical and veterinary products based on its
proprietary sustained release biodegradable polymer drug delivery system,
trade-named ATRIGEL. We currently market the ATRISORB GTR Barrier, a
biodegradable film utilizing the ATRIGEL system, to aid in the guided tissue
regeneration of a tooth's support following periodontal surgery and ATRIDOX, a
minimally invasive subgingival antibiotic therapy for periodontal disease
employing the ATRIGEL System with the antibiotic doxycycline. We are also
developing the ATRISORB-DOXY product, a second-generation guided tissue
regeneration barrier which combines the benefits of the ATRISORB GTR Barrier
with the antibiotic doxycycline for improved clinical outcomes following
periodontal surgery. In the veterinary field, we have developed a product
utilizing the ATRIGEL system to treat periodontal disease in companion animals
which is being marketed by Heska Corporation.
7
9
Atrix's patented ATRIGEL system is comprised of biodegradable polymer
formulations that are administered as flowable compositions (e.g., solutions,
gels, pastes, and putties), which solidify in situ upon contact with body fluids
to form biodegradable implants. The ATRIGEL system is designed to provide
extended localized or systemic drug delivery in a single application, without
the need for surgical implantation or removal. Depending on the intended use or
the specific drug to be delivered via the ATRIGEL system, the release and
degradation rates of the system can be tailored. We believe that the unique
properties of the ATRIGEL system create the potential for a wide variety of
dental, medical and veterinary applications.
RECENT DEVELOPMENTS
On November 24, 1998 Atrix completed the acquisition through merger of
ViroTex Corporation, a drug delivery company which develops over the counter and
prescription products based on proprietary drug delivery systems that provide
topical and transmucosal delivery of medications requiring quick onset of
action. Under the terms of the Agreement and Plan of Reorganization dated
November 24, 1998 (the "Merger Agreement"), the stockholders of ViroTex received
$7,500,000 in cash and $500,000 in shares of Common Stock. In addition, the
stockholders of ViroTex are entitled to receive additional consideration of up
to $3,000,000, payable in shares of Common Stock, upon satisfaction of certain
conditions set forth in the Merger Agreement related to the licensing or sale or
commercialization of certain of ViroTex's technology.
USE OF PROCEEDS
Atrix will receive no proceeds from the sale of the Common Stock by the
Selling Stockholders.
SELLING STOCKHOLDERS
The following table sets forth the name of certain of the Selling
Stockholders and (i) the amount of Shares owned by each such Selling Stockholder
as of December 9, 1998, and (ii) the amount of Common Stock which may be offered
for the account of such Selling Stockholder under this Prospectus as of December
9, 1998. Because the Selling Stockholders may offer some, all or none of their
Common Stock, no definitive estimate as to the number of shares of Common Stock
that will be held by the Selling Stockholders after such offering can be
provided and the following table has been prepared on the assumption that all
shares of Common Stock offered by this Prospectus will be sold.
Principal Amount of Principal Amount Shares of Common
Common Stock Owned of Common Stock Stock Owned After
NAME OF SELLING STOCKHOLDER prior to the Offering Offered Hereby the Offering
--------------------------- --------------------- ----------------- -----------------
GulfStar Group 6,750 6,750 --
Ventures Medical, L.P. 57,806 57,806 --
Miami Corporation, (as agent for
eight trusts) 19,577 19,577 --
Cutler Oil & Gas Corporation 14,686 14,686 --
Miami Corporation 16,315 16,315 --
The Woodlands Venture Capital Company 17,129
New York Life Insurance Company 73,430 73,430 --
Capital Cities Capital, Inc. 31,001 31,001 --
Dr. Bruce W. Miller 15,414 15,414 --
Herbert S. Haigh 9,480 9,480 --
Robert Donovan 4,303 4,303 --
John Kuklinski 5,871 5,871 --
8
10
None of the Selling Stockholders listed above had any material relationship with
Atrix other than as a result of ownership of the Common Stock, within the
three-year period ending on the date of this Prospectus.
DESCRIPTION OF CAPITAL STOCK
The authorized capital stock of Atrix consists of 30,000,000 shares of
capital stock, of which 25,000,000 shares have been designated as Common Stock,
$.001 par value, and 5,000,000 shares have been designated as Preferred Stock,
$.001 par value ("Preferred Stock").
COMMON STOCK
As of September 30, 1998, there were 11,287,760 shares of Common Stock
outstanding and held of record by approximately 2,671 stockholders. Holders of
shares of Common Stock are entitled to one vote per share on matters to be voted
upon by the stockholders of Atrix. The Amended and Restated Certificate of
Incorporation of Atrix (the "Certificate") provides for cumulative voting for
the election of directors on or after the date on which we become aware that any
stockholder has become the beneficial owner, directly or indirectly, of 30% or
more of the outstanding shares of capital stock of Atrix entitled to vote
generally in the election of directors.
PREFERRED STOCK
Under our Certificate, we have authority to issue 5,000,000 shares of
Preferred Stock, in one or more series as determined by the Board of Directors.
No shares of Preferred Stock are currently issued or outstanding. The Board of
Directors may, without further action by the stockholders of Atrix, issue series
of Preferred Stock and fix the rights and preferences of those shares, including
the dividend rights, dividend rates, conversion rights, exchange rights, voting
rights, terms of redemption, redemption price or prices, liquidation preferences
and the number of shares constituting any series or the designation of such
series. The rights of the holders of Common Stock will be subject to, and may be
adversely affected by, the rights of the holders of any Preferred Stock issued
by Atrix in the future.
No class of Atrix's stock carries with it any preemptive right to
subscribe for any securities of Atrix.
PROVISIONS WHICH MAY DELAY A CHANGE OF CONTROL OF THE COMPANY
The Certificate contains certain provisions which may delay or
discourage a change of control of Atrix, including provisions establishing a
classified board of directors, permitting cumulative voting in certain
circumstances, allowing the Board of Directors to issue and determine the
rights, powers and preferences of Preferred Stock without any vote or further
action by the stockholders, establishing a process to enlarge and fill vacancies
on the Board of Directors and deterring certain self-dealing transactions.
Certain of these provisions are designed to increase the likelihood that the
Board of Directors, if presented with a proposal for a business combination or
other major transaction from a third party that has acquired a block of Atrix's
stock, will have sufficient time to review the proposal and possible
alternatives to the proposal and to act in what it believes to be in the best
interests of the stockholders. These provisions may discourage certain types of
non-negotiated transactions which would result in a change of control of Atrix
and are expected to encourage persons seeking to acquire control of Atrix to
consult first with the Board of Directors to negotiate the terms of any proposed
business combination or offer.
RIGHTS PLAN
On September 25, 1998, the Board of Directors of Atrix adopted a
Stockholder Rights Agreement (the "Rights Plan") and distributed one Right for
each outstanding share of Common Stock. The Rights wee issued to holders of
record of Common Stock outstanding on September 25, 1998. Each share of Common
Stock issued after September 25, 1998 will also include one Right, subject to
9
11
certain limitations. Each Right when it becomes exercisable will initially
entitle the registered holder to purchase from the Company one one-hundredth
(1/100th) of a share of Series A Preferred Stock at a price of $67.50 (the
"Purchase Price").
Currently the Rights are attached to outstanding shares of Common
Stock. The Rights are not now exercisable and cannot be transferred separately.
The Rights will become exercisable and separately transferable when the Company
learns that any person or group has acquired beneficial ownership of 15% or more
of the outstanding Common Stock or on such other date as may be designated by
the Board of Directors following the commencement of, or first public disclosure
of an intent to commence, a tender or exchange offer for outstanding Common
Stock that could result in the offeror becoming the beneficial owner of 15% or
more of the outstanding Common Stock. In such circumstances, holders of the
Rights will be entitled to purchase, for the Purchase Price, a number of
hundredths of a share of Series A Preferred Stock equivalent to the number of
shares of Common Stock (or, in certain circumstances, other equity securities)
having a market value of twice the Purchase Price. Beneficial holders of 15% or
more of the outstanding Common Stock, however, would not be entitled to exercise
their Rights in such circumstances. As a result, their voting and equity
interests in the Company would be substantially diluted if the Rights were to be
exercised.
The Rights expire in September 2008, but may be redeemed earlier by the
Company in accordance with the provisions of the Rights Plan.
PLAN OF DISTRIBUTION
The Selling Stockholders may sell the Common Stock in transactions on
the Nasdaq National Market or in privately negotiated transactions, through the
writing of options on the shares or a combination of such methods of sale, at
fixed prices that may be changed, at market prices prevailing at the time of
sale, at prices related to such prevailing market prices or at negotiated
prices. The distribution of the shares through such persons may be effected in
one or more transactions that may take place on the Nasdaq Stock Market,
including block trades or ordinary broker's transactions, or through privately
negotiated transactions or sales to one or more brokers or dealers for resale of
such securities as principals, or otherwise at market prices prevailing at the
time of sale, at prices related to such prevailing market prices or at
negotiated prices. Usual and customary or specifically negotiated brokerage fees
or commissions may be paid by the Selling Stockholders in connection with such
sales. In connection with such sales, the Selling Stockholders and any
participating brokers or dealers may be deemed "underwriters" as such term is
defined in the Securities Act and the commissions paid or discounts allowed to
any of such underwriters, brokers, dealers or agents, in addition to any profits
received on resale of the shares if any such underwriters, brokers, dealers or
agents should purchase any shares as a principal, may be deemed to be
underwriting discounts or commissions under the Securities Act.
From time to time, one or more of the Selling Stockholders may
transfer, pledge, donate or assign such Selling Stockholders' Common Stock to
lenders or others and each of such persons will be deemed to be a "Selling
Stockholder" for purposes of this Prospectus. The number of Selling
Stockholders' Common Stock beneficially owned by those Selling Stockholders who
so transfer, pledge, donate or assign Selling Stockholders' Common Stock will
decrease as and when they take such actions. The plan of distribution for
Selling Stockholders' Common Stock sold hereunder will otherwise remain
unchanged, except that the transferees, pledgees, donees or other successors
will be Selling Stockholders hereunder.
Atrix has agreed to indemnify each of the Selling Stockholders and
controlling persons against certain liabilities, including certain liabilities
under the Securities Act. Insofar as indemnification of the Selling Stockholders
and controlling persons for liabilities arising under the Securities Act may be
permitted pursuant to their agreement, Atrix is aware that, in the opinion of
the SEC, such indemnification is against public policy as expressed in the
Securities Act and, therefore, may be unenforceable.
Atrix has agreed to pay the expenses of registering all of the Common
Stock offered hereby under the Securities Act, including all registration,
filing and exchange listing fees, blue sky expenses, fees of its own counsel and
accountants, and underwriters' fees customarily paid by issuers (excluding
underwriting discounts, commissions and transfer taxes).
10
12
LEGAL MATTERS
Certain legal matters with respect to the shares of Common Stock
offered hereby will be passed upon for Atrix by Morrison & Foerster LLP, Denver,
Colorado.
EXPERTS
The financial statements incorporated into this Prospectus by reference
from Atrix's Annual Report on Form 10-K for the year ended December 31, 1997
have been audited by Deloitte & Touche LLP, independent auditors, as stated in
their report, which is incorporated herein by reference and have been so
incorporated in reliance upon the report of such firm given upon their authority
as experts in accounting and auditing.
11
13
================================================================================
NO DEALER, SALESPERSON OR OTHER INDIVIDUAL HAS BEEN AUTHORIZED TO GIVE ANY
INFORMATION OR TO MAKE ANY REPRESENTATIONS NOT CONTAINED IN THIS PROSPECTUS IN
CONNECTION WITH THE OFFERING COVERED BY THE PROSPECTUS. IF GIVEN OR MADE, SUCH
INFORMATION OR REPRESENTATIONS MUST NOT BE RELIED UPON AS HAVING BEEN AUTHORIZED
BY THE COMPANY. THE PROSPECTUS DOES NOT CONSTITUTE AN OFFER TO SELL OR A
SOLICITATION OF AN OFFER TO BUY THE COMMON SHARES IN ANY JURISDICTION WHERE, OR
TO ANY PERSON TO WHOM, IT IS UNLAWFUL TO MAKE SUCH OFFER OR SOLICITATION.
NEITHER THE DELIVERY OF THE PROSPECTUS NOR ANY SALE HEREUNDER SHALL UNDER ANY
CIRCUMSTANCES, CREATE ANY IMPLICATION THAT THERE HAS NOT BEEN ANY CHANGE IN THE
FACTS SET FORTH IN THE PROSPECTUS OR IN THE AFFAIRS OF THE COMPANY SINCE THE
DATE HEREOF.
TABLE OF CONTENTS
PAGE
----
AVAILABLE INFORMATION................................................
ADDITIONAL INFORMATION...............................................
INCORPORATION OF CERTAIN
DOCUMENTS BY REFERENCE............................................
RISK FACTORS.........................................................
THE COMPANY..........................................................
USE OF PROCEEDS......................................................
SELLING STOCKHOLDERS.................................................
DESCRIPTION OF CAPITAL STOCK.........................................
PLAN OF DISTRIBUTION ................................................
LEGAL MATTERS........................................................
EXPERTS..............................................................
================================================================================
================================================================================
271,762
ATRIX LABORATORIES, INC.
COMMON STOCK
$.001 PAR VALUE
---------------------
PROSPECTUS
---------------------
DECEMBER __, 1998
================================================================================
12
14
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION.
The following table sets forth the expenses payable by the Registrant,
in connection with the sale of securities being registered.
Payable by the
Registrant
--------------
SEC registration fee....................................... $ 906.60
Nasdaq National Market listing fee 5,435.44
Accounting fees and expenses............................... 2,000
Legal fees and expenses.................................... 10,000
Miscellaneous.............................................. 1,500
Total................................................. $19,842.02
The foregoing items, except for the SEC registration fee, are
estimated.
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS.
Section 145 of the Delaware General Corporation Law provides generally
and in pertinent part that a Delaware corporation may indemnify its directors
and officers against expenses, judgments, fines and settlements actually and
reasonably incurred by them in connection with any civil suit or action, except
actions by or in the right of the corporation, or any administrative or
investigative proceeding if, in connection with the matters in issue, they acted
in good faith and in a manner they reasonably believed to be in, or not opposed
to, the best interests of the corporation, and in connection with any criminal
suit or proceeding, if in connection with the matters in issue, they had no
reasonable cause to believe their conduct was unlawful. Section 145 further
provides that in connection with the defense or settlement of any action by or
in the right of the corporation, a Delaware corporation may indemnify its
directors and officers against expenses actually and reasonably believed to be
in, or not opposed to, the best interests of the corporation. Section 145
permits a Delaware corporation to grant its directors and officers additional
rights of indemnification through bylaw provisions and otherwise and to purchase
indemnity insurance on behalf of its directors and officers.
Article Eight of the Certificate of Incorporation of the Registrant
requires the Registrant to indemnify, to the fullest extent permitted by Section
145 of the Delaware General Corporation Law, all directors and officers of the
Registrant, which it has the power to indemnify, from and against any and all
expenses, liabilities or other matters referred to in Section 145.
The Registrant's Certificate of Incorporation also provides in Article
Seven that directors shall not be personally liable to the Registrant or its
stockholders for monetary damages for breach of fiduciary duty as a director,
except for liability (i) for any breach of a director's duty of loyalty to the
Registrant or its stockholders, (ii) for acts or omissions not in good faith or
which involve intentional misconduct or knowing violations of law, (iii) under
Section 174 of the Delaware General Corporation Law or (iv) for any transaction
from which the director derived an improper personal benefit.
Article III, Section 16 of the Registrant's By-laws provides, in
general, that the Registrant shall indemnify its directors and officers to the
fullest extent permitted by the Delaware General Corporation Law.
The Registrant maintains liability insurance coverage for its directors
and officers.
13
15
ITEM 16. EXHIBITS.
The following is a complete list of exhibits filed as part of the
Registration Statement. Exhibit numbers correspond to the numbers in the Exhibit
Table of Item 601 of Regulation S-K.
5.1* Opinion of Morrison & Foerster, LLP as to the legality of the
Securities being registered.
23.1* Consent of Morrison & Foerster, LLP (see Exhibit 5.1).
23.2* Consent of Deloitte & Touche LLP.
4.1 Powers of Attorney (included in the signature page).
- -----------
* Previously filed.
ITEM 17. UNDERTAKINGS.
The Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made,
a post-effective amendment to this registration statement:
(a) to include any prospectus required by Section 10(a)(3) of the
Securities Act of 1933;
(b) to reflect in the prospectus any facts or events arising
after the effective date of the registration statement (or the most
recent post-effective amendment thereof) which, individually or in the
aggregate, represent a fundamental change in the information set forth
in the registration statement. Notwithstanding the foregoing, any
increase or decrease in the volume of securities offered (if the total
dollar value of securities offered would not exceed what was
registered) and any deviation from the low or high end of the
estimated maximum offering range may be reflected in the form of
prospectus filed with the Commission pursuant to Rule 424(b) if, in
the aggregate, the changes in volume and price represent no more than
a 20% change in the maximum aggregate offering price set forth in the
"Calculation of Registration Fee" table in the effective registration
statement;
(c) to include any material information with respect to the plan
of distribution not previously disclosed in the registration statement
or any material change to such information in the registration
statement;
Provided, however, that paragraphs (1)(a) and (1)(b) do not apply if the
registration statement is on Form S-3, Form S-8 or Form F-3, and the information
required to be included in a post-effective amendment by those paragraphs is
contained in periodic reports filed with or furnished to the Commission by the
undersigned pursuant to Section 13 or Section 15(d) of the Securities Exchange
Act of 1934 that are incorporated by reference in the registration statement.
(2) that, for purposes of determining any liability under the
Securities Act of 1933, each filing of the registrant's annual report pursuant
to section 13(a) or section 15(d) of the Securities Exchange Act of 1934 (and,
where applicable, each filing of an employee benefit plan's annual report
pursuant to section 15(d) of the Securities Exchange Act of 1934) that is
incorporated by reference in the registration statement shall be deemed to be a
new registration statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be the initial bona
fide offering thereof.
(3) insofar as indemnification for liabilities arising under the
Securities Act of 1933 may be permitted to directors, officers and controlling
persons of the registrant pursuant to the foregoing provisions, or otherwise,
14
16
the registrant has been advised that in the opinion of the Securities and
Exchange Commission such indemnification is against public policy as expressed
in the Act and is, therefore, unenforceable. In the event that a claim for
indemnification against such liabilities (other than the payment by the
registrant of expenses incurred or paid by a director, officer or controlling
person of the registrant in the successful defense of any action, suit or
proceeding) is asserted by such director, officer or controlling person in
connection with the securities being registered, the registrant will, unless in
the opinion of its counsel the matter has been settled by controlling precedent,
submit to a court of appropriate jurisdiction the question whether such
indemnification by it is against public policy as expressed in the Act and will
be governed by the final adjudication of such issue.
15
17
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as amended,
the Registrant certifies that it has reasonable grounds to believe that it meets
all of the requirements for filing this amendment to Form S-3 and has duly
caused this Registration Statement to be signed on its behalf by the
undersigned, thereunto duly authorized, in the City of Fort Collins, Colorado on
December 15, 1998.
ATRIX LABORATORIES, INC.
By: /s/ John E. Urheim
---------------------------------------
John E. Urheim, Chief Executive Officer
16
18
Pursuant to the requirements of the Securities Act of 1933, as amended,
this Registration Statement has been signed by the following persons in the
capacities and on the dates indicated.
SIGNATURE TITLE DATE
--------- ----- ----
* Director December 15, 1998
- ----------------------------------------
David R. Bethune
* Director December 15, 1998
- ----------------------------------------
H. Stuart Campbell
* Director December 15, 1998
- ----------------------------------------
Dr. D. Walter Cohen
* Director December 15, 1998
- ----------------------------------------
Dr. Jere E. Goyan
* Director December 15, 1998
- ----------------------------------------
Dr. R. Bruce Merrifield
* Director December 15, 1998
- ----------------------------------------
C. Rodney O'Connor
* Chairman of the Board December 15, 1998
- ----------------------------------------
William C. O'Neil, Jr.
* Vice President, Finance and December 15, 1998
- ---------------------------------------- Assistant Secretary
Brian G. Richmond (Principal Financial Officer)
* Director December 15, 1998
- ----------------------------------------
Dr. G. Lee Southard
* Vice Chairman, Chief Executive Officer December 15, 1998
- ---------------------------------------- and Director
John E. Urheim
* By: /s/ John E. Urheim
----------------------------------
John E. Urheim,
as attorney-in-fact
17
19
EXHIBIT INDEX
5.1* Opinion of Morrison & Foerster, LLP as to the legality of the
Securities being registered.
23.1* Consent of Morrison & Foerster, LLP (see Exhibit 5.1).
23.2* Consent of Deloitte & Touche LLP.
24.1 Powers of Attorney (included in the signature page).
- -----------
* Previously filed.